A variety of medical and surgical procedures involve the insertion, navigation and placement of guidewires, catheters, scopes and other devices that are used to perform therapeutic or diagnostic procedures at intracorporeal treatment sites (e.g., e.g., within a vessel, cavity or passageway of the body). In many of these procedures, the guidewire, catheter, scope or other device must be carefully advanced through tortuous or branched body passages (e.g., nasal passages, blood vessels, gastrointestinal tract, biliary tree, urinary tract, etc.) and/or around existing anatomical structures, in order to reach an intended location. In some cases, the physician-in-training may be able to alter the shape of the device as it is advanced though the body passageways (e.g., as in the case of a steerable or deflectable guidewire, catheter, scope or other device). In other cases, the device may be of a substantially fixed configuration (e.g., straight or curved). In either event, the physician-in-training must learn techniques for pre-shaping (if necessary), advancing and navigating such devices through the available body passageways, around certain anatomical structures and to their intended intracorporeal locations.
In some cases, anatomical models have been used for training physicians or other health professionals in the insertion, navigation, positioning and/or use of guidewires, catheters, scopes or other devices. Such uses of anatomical models can sometimes enable physicians-in-training and other professions-in-training to gain initial experience in performing certain procedures or techniques in a relaxed, non-clinical setting before proceeding to more challenging work in cadavers, laboratory animals or actual human patients.
One particular anatomical model that has been used for training surgeons in the performance of endoscopic sinus surgery is the SurgTrainer™ Human Nasal Model for Endonasal Surgery Training available from SurgTrainer, Ltd., 4-4-21, Kasuga, Tsukuba City, Ibaraki 305-0821 Japan. Also see, see, Yamauchi Y, Yamashita J, Mochimaru M, Fukui Y, Niikura M, Uno H, Yokoyama K, “Development of a Silicone Model for Endoscopic Sinus Surgery,” proc CARS 99, p. 1039, 1999). This device generally includes a head-shaped housing into which various anatomical inserts may be interchangeably inserted and a soft plastic covering representing the skin and soft tissue structures of the patient's face. The interchangeable inserts represent various bone/sinus configurations representative of pathological conditions and, in at least some cases, are designed to be incised, drilled or cut by the surgeon undergoing training. This model is purported to be x-ray and CT compatible and may be used in conjunction with image guided surgical systems. However, devices such as the SurgTrainer™ Human Nasal Model for Endonasal Surgery Training may be less than optimal for training physicians in the performance of newer, less traumatic endonasal and sinus procedures. For example, new catheter-based procedures have been developed by Acclarent, Inc. of Menlo Park, Calif. for the performance of less traumatic Sinus and endonasal surgeries. These new procedures include, but are not limited to, uncinate-sparing procedures, uncinate-sparing ethmoidotmy procedures and implantation of drug delivery devices for treatment of paranasal sinusitis, using various catheters, instruments and advanced imaging techniques (Acclarent, Inc., Menlo Park, Calif.). Examples of these new devices, systems and methods are described in incorporated U.S. patent application Ser. Nos. 10/829,917 entitled Devices, Systems and Methods for Diagnosing and Treating Sinusitis and Other Disorders of the Ears, Nose and/or Throat; 10/944,270 entitled Apparatus and Methods for Dilating and Modifying Ostia of Paranasal Sinuses and Other Intranasal or Paranasal Structures; 11/116,118 entitled Methods and Devices for Performing Procedures Within the Ear, Nose, Throat and Paranasal Sinuses filed Apr. 26, 2005 and 11/150,847 filed Jun. 10, 2005, of which this application is a continuation-in-part. Catheter-based procedures are performed using various types of guidance including but not limited to C-arm fluoroscopy, transnasal endoscopy, intraoperative CT scan guidance, optical image guidance and/or electromagnetic image guidance.
Applicant has previously invented a device that may be used for simulated insertion and positioning of a working device (e.g., a balloon catheter) at a desired treatment site (e.g., within the ostium of a paranasal sinus). This device includes an indicator apparatus that provides an indication of when the working device has been used to cause some particular effect without causing substantial dismantling or destruction of the anatomical model. The indicator apparatus may indicate either a desired effect (e.g., the intended therapeutic or diagnostic effect of the working device) or an undesired effect (e.g., a complication, side effect, error, mistake or untoward effect) resulting from use of the working device. This device is described in co-pending U.S. patent application Ser. No. 11/527,773 entitled Anatomical Models and Methods for Training and Demonstration of Medical Procedures, the entire disclosure of which is expressly incorporated herein by reference.
There remains a need in the art for the development of additional devices and methods useable for training physicians and other health professionals in the insertion, navigation, placement and use of guidewires, catheters, scopes and other medical or surgical devices.